FRINDOVYX Drug Patent Profile

When do Frindovyx patents expire, and what generic alternatives are available?

Frindovyx is a drug marketed by Avyxa Holdings and is included in one NDA. There are two patents protecting this drug.

This drug has one patent family member in one country.

The generic ingredient in FRINDOVYX is cyclophosphamide. There are nineteen drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the cyclophosphamide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Frindovyx

A generic version of FRINDOVYX was approved as cyclophosphamide by BAXTER HLTHCARE on May 21^st, 2008.

Summary for FRINDOVYX

International Patents:	1
US Patents:	2
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for FRINDOVYX

FRINDOVYX is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Avyxa Holdings	FRINDOVYX	cyclophosphamide	SOLUTION;INTRAVENOUS	210852-002	Jun 7, 2023		RX	Yes	Yes			Y
Avyxa Holdings	FRINDOVYX	cyclophosphamide	SOLUTION;INTRAVENOUS	210852-003	Jun 7, 2023		RX	Yes	Yes			Y
Avyxa Holdings	FRINDOVYX	cyclophosphamide	SOLUTION;INTRAVENOUS	210852-002	Jun 7, 2023		RX	Yes	Yes			Y
Avyxa Holdings	FRINDOVYX	cyclophosphamide	SOLUTION;INTRAVENOUS	210852-003	Jun 7, 2023		RX	Yes	Yes			Y
Avyxa Holdings	FRINDOVYX	cyclophosphamide	SOLUTION;INTRAVENOUS	210852-001	Jun 7, 2023		RX	Yes	Yes			Y

International Patents for FRINDOVYX

See the table below for patents covering FRINDOVYX around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2016005962

Last updated: July 29, 2026

FRINDOVYX investment scenario and fundamentals analysis: FDA status, IP exclusivity, launch risks, and competitive outlook

FRINDOVYX is not a uniquely identifiable drug product for investment-grade IP and exclusivity analysis from authoritative public sources. No reliable mapping to an FDA-approved active ingredient, NDA/BLA holder, dosage form, or Orange Book record is available in the provided context.

What is FRINDOVYX and what active ingredient does it contain?

Answer: Not determinable from available information in this prompt. Without a verifiable active ingredient, strength, dosage form, and sponsor/NDA holder, IP status and investment fundamentals cannot be stated with the precision required for patent, exclusivity, and litigation risk modeling.

What FDA application type does FRINDOVYX use (NDA, BLA)

Not determinable.

What therapeutic area and dosing category does FRINDOVYX target

Not determinable.

What patents protect FRINDOVYX and how long is the exclusivity runway?

Answer: Not determinable. Patent estate analysis requires identifying the relevant Orange Book reference listed drug (RLD), application number(s), and the specific FRINDOVYX formulation.

How many Orange Book-listed patents cover FRINDOVYX

Not determinable.

When do FRINDOVYX patents expire (US composition, method, and formulation)

Not determinable.

When does FRINDOVYX lose exclusivity (NCE, 505(b)(2), pediatric, orphan, or other exclusivity types)

Not determinable.

What is the Orange Book status of FRINDOVYX (RLD, patents, exclusivity codes)?

Answer: Not determinable.

Is FRINDOVYX listed as an RLD

Not determinable.

What exclusivity code applies

Not determinable.

What generic entry risks exist for FRINDOVYX (ANDA, Paragraph IV)

Answer: Not determinable. Paragraph IV risk depends on identified patent numbers, expiry dates, and whether any ANDA notice letters or court filings exist for those specific patents.

Have any ANDA Paragraph IV challenges been filed against FRINDOVYX

Not determinable.

What is the typical settlement posture for the relevant patent(s)

Not determinable.

What patent litigation affects FRINDOVYX (infringement, IPR, or ITC)?

Answer: Not determinable. Litigation timelines must be tied to known case dockets and asserted US patents.

What courts handle FRINDOVYX disputes (DTSA/ Hatch-Waxman, venue)

Not determinable.

What patents are asserted in FRINDOVYX actions

Not determinable.

How strong is the patent estate for FRINDOVYX (claims coverage and likely invalidity vectors)?

Answer: Not determinable without the identity of asserted/Orange Book patents and their claim scopes.

Composition of matter strength

Not determinable.

Method-of-use and manufacturing barriers

Not determinable.

Formulation and delivery system protection

Not determinable.

What formulations are protected by FRINDOVYX patents (dosage forms, strengths, specs)?

Answer: Not determinable.

Tablet vs capsule vs injection vs inhalation

Not determinable.

Any REMS, stability, or manufacturing IP hooks

Not determinable.

How does FRINDOVYX compare with competing drugs (class position and pricing exposure)?

Answer: Not determinable without knowing the active ingredient and indication.

Who are FRINDOVYX competitors in the same mechanism-of-action or indication

Not determinable.

What is the expected pricing and payer dynamic

Not determinable.

When does FRINDOVYX face FDA timing pressure (CRL, labeling negotiations, launch readiness)?

Answer: Not determinable. FDA milestones require verified approval history, regulatory pathway, and labeling.

What is the FDA approval date and launch schedule

Not determinable.

Any post-approval safety updates that alter market access

Not determinable.

What biosimilar risk exists for FRINDOVYX (if biologic)

Answer: Not determinable. Biosimilar risk requires confirmation that FRINDOVYX is a biologic (BLA) and identification of reference product status.

If FRINDOVYX is biologic, what biosimilar pathways are relevant

Not determinable.

Which companies are challenging FRINDOVYX and what are their launch plans?

Answer: Not determinable. This requires identifying any Paragraph IV ANDAs, challengers, and stated commercial launch dates.

Investment scenario: bull/base/bear pathways for FRINDOVYX launch and erosion

Answer: Not determinable. A high-integrity scenario model requires (1) verified FDA approval status and date, (2) Orange Book patent and exclusivity expiry schedule, (3) known ANDA/BLA competitors and litigation posture, and (4) verified commercialization metrics (sales ramp, prescriptions, reimbursement trajectory).

Key Takeaways

• FRINDOVYX cannot be analyzed for investment-grade fundamentals, IP exclusivity, litigation, or generic/biosimilar risk because the drug cannot be mapped to an identifiable FDA-approved product, active ingredient, sponsor, NDA/BLA application, or Orange Book record from the information provided.
• No actionable patent estate timeline, exclusivity runway, Paragraph IV risk, or competitive erosion profile can be produced without a verifiable drug identity.

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FAQs

1. How do I verify FRINDOVYX Orange Book status and exclusivity codes?
   Not possible from the provided context.

2. What data fields drive a Paragraph IV risk assessment for a specific drug?
   Patent numbers listed for the RLD, associated expiry dates, and any ANDA notice letters/case filings tied to those patents.

3. What is the typical impact of pediatric exclusivity or orphan exclusivity on generic launch timing?
   It can extend exclusivity beyond patent expiry, but the effect cannot be stated for FRINDOVYX without the exact exclusivity basis.

4. How is biologic “biosimilar risk” modeled when exclusivity and interchangeability rules apply?
   Requires biologic confirmation (BLA), reference product exclusivity dates, and biosimilar pathway markers; not determinable here.

5. What commercial KPIs should be used to underwrite launch success for an Rx drug?
   Prescription volumes, net price and payer mix, channel inventory, and time-to-formulary placement; disease area and product identity are required to contextualize.

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References (APA)

No sources were cited because FRINDOVYX could not be reliably identified to specific FDA/Orange Book/IP and litigation records in the provided prompt.